The study results, released today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco, also showed low complication rates, including no incidence of device-related cardiac death, myocardial infarction or intraprocedural hypotension. St. Jude acquired the HeartMate PHP when it paid $3 billion for Thoratec last week.

“We are excited to share the results of Shield I, which support the safety and performance of the HeartMate PHP device,” principal investigator Dr. Dariusz Dudek, of the University Hospital in Krakow, said in prepared remarks. “The data from Shield I demonstrate that the HeartMate PHP device is a highly promising technology that should be considered for high-risk patients, such as those with advanced heart failure or who may be at risk of cardiogenic shock, undergoing PCI procedures.”

“Globally, there’s a significant opportunity for patients to benefit from cardiovascular pumps that address an otherwise unmet clinical need for complete circulatory support during high-risk PCI procedures,” added St. Jude chief medical officer Dr. Mark Carlson. “The Shield I study results demonstrate the consistent and reliable circulatory support offered by the HeartMate PHP cardiac assist device, which was designed as a novel advancement to traditional catheter-based support devices.”

Meeting consumer demands for home healthcare technology requires a keen knowledge of user behavior. Here are four ways companies are approaching the market. by Scott Thielman, Product Creation Studio The global smart home healthcare market is exploding as more medical devices are designed for use wherever the patient is, including at home. A report by Research… […]

Okay Industries (New Britain, Conn.) announced that it has appointed Angela Dillon as its new marketing manager. As marketing manager, Dillon willed strategic initiative that will promote the Okay brand, support business development and manage both internal and external communications for talent recruitment and retention. “I am excited to announce this new role for Angela,”… […]

SIG Medical (Hershey, Penn.) has received FDA 510(k) clearance for its enhanced AdvantageRib System, the K183317. The system is the third rib fracture system from SIG Medical that has received 510(k) clearance recently and is being commercialized. The most recent 510(k) includes new implants that treat patients, as well as the entire spectrum of bone… […]

Starr Surgical (Monrovia, Calif.) recently announced that it has signed a strategic cooperation agreement with the Smile Eyes group in Germany and Austria. The Smile Eyes group is an alliance of more than 80 eye experts in 13 vision correction eye centers in Germany and Austria. Through the agreement, EVO Visian ICL lenses will be… […]

One of the world’s largest medical device contract manufacturers, Phillips-Medisize is making a business play to provide the technological back end for connected drug delivery devices. Phillips-Medisize used to be all about the housings, assembly and packaging that went into finished drug-delivery devices. Electronics was something that other contract manufacturers did. Within a few years,… […]

Summit Medical recently announced that it has expanded its St. Paul, Minn. manufacturing facility with an additional 15,000 sq. ft. The addition opened on Feb. 11. The expansion will become a secondary facility for the company’s headquarters that is located less than a mile away. It will also serve as a master distribution center. “The… […]

WTWH Media and MassDevice.com announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices… […]

Apollo Endosurgery (NSDQ:APEN) has reported key data from 1,000 patients who underwent endoscopic gastroplasty using the company’s OverStitch device. Published in the journal Gastrointestinal Endoscopy, the data include a mean total weight loss of 14.8%±8.5% at 18 months. Three months following surgery, the impact on obesity-related comorbidities included the complete remission of: 13 of 17 cases… […]

Royal Philips (NYSE:PHG) said it has launched a new mobile C-arm imaging platform, Zenition. Mobile C-arms are X-ray systems that are brought into the operating room (OR) to provide live image guidance during a wide range of surgeries including orthopedic, trauma and vascular procedures. The Zenition mobile C-arm platform brings together innovations in image capture, image… […]

By Allison Strochlic, Emergo Group I just had a baby – my second daughter. This means that, like over 98% of my fellow American moms-to-be, I checked into a local hospital to have nurses and doctors oversee what I hoped would be the smooth delivery of my baby. This entitled me to the firsthand experience… […]